DarDar Nutrition Study in HIV Breastfeeding Women

Not Applicable

Completed

• Conditions: Low Birth Weight
• Interventions: Dietary Supplement: Porridge protein calorie supplement; Dietary Supplement: multivitamin

• Registration Number: NCT01461863
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health outcomes for HIV-infected pregnant women and their infants.

Detailed Description

In resource poor regions of the world where HIV is endemic, especially countries in sub-Saharan Africa, nutrition plays a critical role in HIV disease. Nutrition affects the health of HIV-infected women and children, and may influence the risk of mother to infant transmission of HIV through breast milk. Nutrition influences the risk of tuberculosis (TB) and TB disease severity. Existing research has focused on the role of micronutrients in HIV disease outcomes but has not addressed the role of protein calorie supplementation (PCS) in subpopulations of patients with HIV disease at high risk, specifically, HIV-infected women who are either breast feeding or have active TB. Our hypotheses are that administration of a culturally acceptable PCS is a practical, sustainable and effective strategy to: 1) decrease HIV viral load in plasma and breast milk of breast feeding women, enhance passively transferred immune mediators in breast milk, and improve HIV outcomes in women and their breast-fed infants and, 2) decrease HIV viral load, enhance TB-specific T cell immunity, and improve outcomes in women with HIV and active TB.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2018-04-30
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-17
• Results First Posted: 2018-08-14
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• HIV+ women
• 2nd trimester of pregnancy
• Residency in Dar for duration of breastfeeding
• Plan to exclusively breastfeed

Exclusion Criteria

• High risk pregnancy (e.g., diabetes, pre-eclampsia)
• Women with allergy to components of PCS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protein calorie supplement	Porridge protein calorie supplement	250 gm daily of specially designed porridge plus standard multivitamin
Multivitamin	multivitamin	Standard multivitamin control

Primary Outcome Measures

Name	Time	Method
Infant Weight	3 months	Infant weight at 3 months

Secondary Outcome Measures

Name	Time	Method
Maternal BMI at 9 Months	9 months	Maternal BMI at 9 months

Trial Locations

Locations (1)

Muhimbili University of Health and Allied Sciences; 🇹🇿 Dar es Salaam, Tanzania